Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults

Hypercholesterolemia Clinical Trial

Official title:

Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353820
• Other study ID #: NU280
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: October 26, 2016
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• male and female aged 18-75 years;

• BMI between 19 and 30 kg/m2,

• LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,

• stabilized hypercholesterolemia (since more than 3 months),

• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),

• used to consume dairy products,

• for female: effective contraceptive methods used,

• agreeing to a written informed consent

Exclusion Criteria:

• plasma triglycerides (TG) levels > 350 mg/dL (4 mmol//L),

• any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,

• known allergy or hypersensitivity to milk proteins,

• systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,

• subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,

• subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,

• diabetic subjects (type I and type II),

• any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,

• for female subject: pregnancy, breast feeding or intention to become pregnant during the study,

• for female subject: subject likely to change her contraceptive method during the study,

• active heavy cigarette smokers (reported more than 20 cigarettes / day),

• subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL
1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis )
• 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus
2- Intervention with control product

Locations

Country	Name	City	State
Czech Republic	AMED s.r.o (Poliklinika Budejovická)	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Czech Republic,